May 4, 2020
Masimo (NASDAQ: MASI) announced today the findings of a study published in the Journal of Anesthesiology and Reanimation Specialists’ Society in which researchers compared two methods of intraoperative fluid management during orthopedic spinal surgery, including Masimo PVi®. In comparison to invasive and intermittent central venous pressure (CVP) measurement, noninvasive and continuous pleth variability index (PVi) provided “better cardiac stabilization with less fluid replacement, and more accurate results in the evaluation of intravascular volume status.”1
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Masimo Radical-7® with PVi® (Photo: Business Wire)
Dr. Eralp Çevikkalp and colleagues at Celal Bayar University in Turkey, noting the importance of intraoperative fluid management during surgery and the drawbacks of traditional invasive, static fluid assessment methods such as CVP and mean arterial pressure (MAP), investigated whether PVi might provide an effective noninvasive and dynamic alternative. In a randomized, controlled trial of 100 adult patients undergoing elective posterior lumbar stabilization surgery, they compared fluid loading-induced changes as guided by PVi and by CVP. The patients were divided into two equally sized groups. In the PVi group, patients were continuously monitored using a Masimo Radical-7® Pulse CO-Oximeter®, and a PVi threshold of > 14% was used to determine whether fluid was administered. (For patients with a PVi > 14%, a 250 mL crystalloid solution was administered every 5 minutes; for patients with a PVi < 14%, a 4 mL fluid infusion was administered.) In the control group, fluid administration was determined using CVP, other traditional parameters, and the 4-2-1 rule. In both groups, lactate, hemoglobin, and hematocrit levels were also recorded.
The researchers found that the mean volume of intraoperative fluid replacement was 1914 ± 542.86 mL in the PVi group and 3522 ± 1098.1 mL in the control group (p < 0.05). They found that the mean units of intraoperative red blood cells (RBC) transfused was 0.08 ± 0.27 units in the PVi group and 0.42 ± 0.57 units in the control group (p < 0.05). Differences between the groups in postoperative RBC units transfused and intraoperative hemoglobin levels were not significant.
The researchers concluded, “The present study has indicated that PVi monitoring is more valuable than CVP monitoring because it is noninvasive, provides better cardiac stabilization with less fluid replacement, and [provides] more accurate results in the evaluation of intravascular volume status. Failure to follow up the duration of surgery and postoperative complications are the most important limitations in our study.”
PVi has not been cleared by the FDA to assess fluid responsiveness.
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Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. Our mission is to improve patient outcomes and reduce the cost of care. Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.2 Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,3 improve CCHD screening in newborns,4 and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.5-7 Masimo SET® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,8 and is the primary pulse oximetry at 9 of the top 10 hospitals listed in the 2019-20 U.S. News and World Report Best Hospitals Honor Roll.9 Masimo continues to refine SET® and in 2018, announced that SpO2 accuracy on RD SET® sensors during conditions of motion has been significantly improved, providing clinicians with even greater confidence that the SpO2 values they rely on accurately reflect a patient’s physiological status. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), RPVi™ (rainbow® PVi), and Oxygen Reserve Index (ORi™). In 2013, Masimo introduced the Root® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine® Brain Function Monitoring, O3® Regional Oximetry, and ISA™ Capnography with NomoLine® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7® and Radius PPG™, portable devices like Rad-67™, fingertip pulse oximeters like MightySat® Rx, and devices available for use both in the hospital and at home, such as Rad-97®. Masimo hospital automation and connectivity solutions are centered around the Iris® platform, and include Iris Gateway®, Patient SafetyNet, Replica™, Halo ION™, UniView™, and Masimo SafetyNet™. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature/.
ORi and RPVi have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo PVi® and Radical-7®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo PVi and Radical-7, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.